Back to results

LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease (LiverPAL)

Primary Purpose

Liver Disease Chronic, End Stage Liver DIsease, Cirrhosis

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LiverPAL

About this trial

This is an interventional supportive care trial for Liver Disease Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patient Inclusion Criteria: Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent: Ascites (requiring diuretics or serial large volume paracenteses) Spontaneous bacterial peritonitis Hepatic hydrothorax (requiring diuretics) Variceal bleed (with one or more occurrences) Overt hepatic encephalopathy (requiring medications) Ability to comprehend English Patient Exclusion Criteria: Prior history of liver transplantation Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer) Presence of hepatocellular carcinoma beyond Milan criteria Are already receiving hospice care Receive a score of <10 on the Simplified Animal Naming Test Caregiver Inclusion Criteria Adult caregiver (≥ 18 years of age) A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone Ability to comprehend English and can complete questionnaires Caregiver Exclusion Criteria 1. Inability to comprehend English

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Hepatology Care

Usual Hepatology Care with Early Palliative Care

Arm Description

Usual hepatology care

Usual hepatology care with early palliative care

Outcomes

Primary Outcome Measures

Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks

Compare patient quality of life (FACIT-Pal) scores up to 4 weeks adjusting for baseline quality of life scores between the study arms. Score range 0-184 with higher scores indicating better quality of life.

Secondary Outcome Measures

Patient FACIT-Pal Score longitudinally between study arms

Compare patient quality of life (FACIT-Pal) scores longitudinally between the study arms. Score range 0-184 with higher scores indicating better quality of life.

Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)

Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden.

Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)

Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms.

Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)

Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.

Patient Depression Scores (Patient Health Questionnaire-9, PHQ-9)

Compare patient depression scores (PHQ-9) between study arms. Score range 0-27 with higher scores indicating higher depression.

Patient Quality of Life (PROMIS-29+2)

Compare patient quality of life (PROMIS-29+2) scores between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores.

Patient End-of-Life (EOL) Care Communication with Caregivers

"Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"

Patient End-of-Life (EOL) Care Communication with Clinicians

"Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"

Documentation of Patient End-of-Life (EOL) Care Preferences

Compare documentation of EOL care preferences in the electronic health record between study arms since baseline.

Full Information

NCT ID

NCT05998330

First Posted

August 11, 2023

Last Updated

September 21, 2023

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05998330

Brief Title

LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

Acronym

LiverPAL

Official Title

LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 20, 2023 (Actual)

Primary Completion Date

July 2027 (Anticipated)

Study Completion Date

July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

Detailed Description

The main purpose of this study is to compare two types of care - usual hepatology care and usual hepatology care with early involvement of palliative care clinicians to see which is better for improving the experience of hospitalized patients with advanced liver disease (AdvLD). The investigators aim to find out whether introducing hospitalized patients with AdvLD to the palliative care team that specializes in symptom management can improve the quality of life and physical and psychological symptoms that patients and families experience during their hospitalizations as well as enhance the quality of patients' end of life care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Disease Chronic, End Stage Liver DIsease, Cirrhosis, Cirrhosis, Liver, Advanced Cirrhosis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Usual Hepatology Care

Arm Type

No Intervention

Arm Description

Usual hepatology care

Arm Title

Usual Hepatology Care with Early Palliative Care

Arm Type

Experimental

Arm Description

Usual hepatology care with early palliative care

Intervention Type

Behavioral

Intervention Name(s)

LiverPAL

Intervention Description

The intervention include integrating early palliative care with usual hepatology care to evaluate and treat patients' symptoms, enhance their illness and prognostic understanding, support their coping, and coordinate their serious illness, transitional, and end-of-life care.

Primary Outcome Measure Information:

Title

Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks

Description

Time Frame

Up to 4 weeks

Secondary Outcome Measure Information:

Title

Patient FACIT-Pal Score longitudinally between study arms

Description

Compare patient quality of life (FACIT-Pal) scores longitudinally between the study arms. Score range 0-184 with higher scores indicating better quality of life.

Time Frame

Up to 6 months

Title

Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)

Description

Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden.

Time Frame

Up to 6 months

Title

Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)

Description

Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms.

Time Frame

Up to 6 months

Title

Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)

Description

Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.

Time Frame

Up to 6 months

Title

Patient Depression Scores (Patient Health Questionnaire-9, PHQ-9)

Description

Compare patient depression scores (PHQ-9) between study arms. Score range 0-27 with higher scores indicating higher depression.

Time Frame

Up to 6 months

Title

Patient Quality of Life (PROMIS-29+2)

Description

Time Frame

Up to 6 months

Title

Patient End-of-Life (EOL) Care Communication with Caregivers

Description

"Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"

Time Frame

Final assessment prior to patient death or at 6 months

Title

Patient End-of-Life (EOL) Care Communication with Clinicians

Description

"Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"

Time Frame

Final assessment prior to patient death or at 6 months

Title

Documentation of Patient End-of-Life (EOL) Care Preferences

Description

Compare documentation of EOL care preferences in the electronic health record between study arms since baseline.

Time Frame

After patient death, up to 60 months

Other Pre-specified Outcome Measures:

Title

Patient End-of-Life (EOL) Care

Description

Compare rate of receipt of intensive EOL care (renal replacement therapy, mechanical ventilation, and/or cardiopulmonary resuscitation or death in the intensive care unit) between study arms.

Time Frame

Within 30 days of patient death

Title

Caregiver Quality of Life (PROMIS-29+2)

Description

Compare caregiver quality of life (PROMIS-29+2) between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores.

Time Frame

Up to 6 months

Title

Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)

Description

Compare caregiver depression symptoms (HADS-D) between study arms. Score range 0-21 with higher scores indicating higher depression symptoms.

Time Frame

Up to 6 months

Title

Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms.

Description

Compare caregiver anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.

Time Frame

Up to 6 months

Title

Caregiver Depression Scores (Patient Health Questionnaire-9, PHQ-9)

Description

Compare caregiver depression scores (PHQ-9) between study arms. Score range 0-27 with higher scores indicating higher depression.

Time Frame

Up to 6 months

Title

Caregiver Burden (Zarit Burden Index 12, ZBI-12)

Description

Compare caregiver burden scores (ZBI-12) between study arms. Score range 0-48 with higher scores indicating higher caregiver burden.

Time Frame

Up to 6 months

Title

Receipt of goal-concordant end-of-life care - patient wishes followed

Description

Bereaved caregivers will be asked "In [participant's] opinion, to what extent were [the patient's] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients' wishes a great deal."

Time Frame

Within 30 days of patient death

Title

Quality of Life Near Death (QOD)

Description

Bereaved caregivers will be asked "Just prior to the death of [the patient] (eg, his/her last week; when last seen), how would [participant] rate [the patient's] level of…" (1) "psychological distress?" (0 = none; 10 = extremely upset); (2) "physical distress?" (0 = none; 10 = extremely distressed); and (3) "overall quality of life in the last week of life/death?" (0 = worst possible; 10 = best possible). Ratings for these three items will be averaged (with reverse coding for the psychological and physical distress items). Scores range 0-10 with higher composite scores representing better QOD.

Time Frame

After patient death, up to 60 months

Title

Prolonged Grief Disorder (PG-13-R)

Description

Compare rates of prolonged grief disorder (PG-13-R) among bereaved caregivers between study arms. Score range 10-50 for symptom items with higher scores indicating worsening symptoms.

Time Frame

At least 12 months after patient death, up to 60 months

Title

Healthcare Utilization at End-of-Life - Hospice

Description

Compare rates of hospice utilization (yes/no) between study arms.

Time Frame

After patient death, up to 60 months

Title

Healthcare Utilization at End-of-Life - Hospice length of stay

Description

Compare number of days in hospice for patients admitted to hospice between study arms.

Time Frame

After patient death, up to 60 months

Title

Healthcare Utilization - Days alive and out of the hospital

Description

Compare days alive and out of the hospital at 6 months (180 days) after randomization

Time Frame

Up to 6 months

Title

Healthcare Utilization - liver transplantation

Description

Compare rates of liver transplantation (yes/no) between study arms

Time Frame

Up to 60 months

Title

Patient Coping (Brief COPE)

Description

Compare patient coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.

Time Frame

Up to 6 months

Title

Caregiver Coping (Brief COPE)

Description

Compare caregiver coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.

Time Frame

Up to 6 months

Title

Patient Feeling Heard and Understood Scale

Description

We will use the validated 4-item scale "Feeling Heard and Understood" as a self-reported measure capturing seriously ill patients' global assessment of their health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16.

Time Frame

Up to 6 months

Title

Caregiver Feeling Heard and Understood Scale

Description

We will use the validated 4-item scale "Feeling Heard and Understood" as a self-reported measure capturing seriously ill patients' caregivers' global assessment of their loved one's health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16.

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lucinda Li, BS

Phone

617-726-3670

luli1@mgh.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Ennie Zhu, AB

Phone

617-724-1316

ezhu3@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nneka Ufere, MD MSCE

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lucinda Li, BS

Phone

617-726-3670

luli@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Enya Zhu, BA

Phone

617-724-1316

ezhu3@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Nneka Ufere, MD MSCE

12. IPD Sharing Statement

Learn more about this trial

LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

We'll reach out to this number within 24 hrs